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Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Varian Medical Systems
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02111681
First received: April 9, 2014
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to test the use of Calypso beacon implants as a way to determine where the lung tumor is located during radiation treatment. The Calypso beacons are small devices that are implanted in the lungs, near the tumor. They are able to send a signal to a tracking system to show where they are, and where the tumor is, as the patient holds their breath for the radiation treatment. The investigators want to find out what effects, good and/or bad, that this has on the patient and the way they treat the cancer in your lungs.


Condition Intervention
Non-small Cell Lung Cancer (NSCLC)
Device: Calypso Beacon Implantation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • feasibility of Calypso transponders [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Feasibility is defined as completion of all treatments using the DIBH treatment plan and Calypso transponders.


Secondary Outcome Measures:
  • reproducibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    We will compare the visual vs no visual biofeedback treatments (done for each patient) by the number of treatment interruptions.

  • measure the residual intrafraction tumor motion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    will be measured in all 3 dimensions and the euclidean distance will be calculated, which will then be correlated with the normal tissue dosimetry by regression analysis.


Estimated Enrollment: 30
Study Start Date: April 2014
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calypso-based Deep Inspiration Breath Hold (DIBH)

This trial will investigate the feasibility of implanted anchored Beacon ® electromagnetic lung transponders (Calypso ®) to guide and monitor deep-inspiration breathhold (DIBH) treatments in patients with inoperable thoracic malignancies.

Bronchoscopic Calypso Beacon Implantation, Simulation - Free-breathing scan - 4D CT scan,- DIBH CT scan Radiation - Treatment setup, - 2 minute Calypso signal recording, - RT treatment with DIBH with or without visual biofeedback Follow-up - 3 and 6 months after RT with diagnostic CT chest

Device: Calypso Beacon Implantation
Bronchoscopic Calypso Beacon Implantation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologic proof of malignancy suitable for thoracic radiation therapy
  • Patients planning to undergo radiation therapy for primary or recurrent carcinomas of the lung or oligo-metastatic carcinoma to the lung.
  • Age ≥ 18 years old
  • KPS ≥ 60%
  • Ability to hold their breath for >20 seconds for 5 times
  • Patients who are able to tolerate flexible bronchoscopy
  • Patients with life expectancy of at least 12 months
  • Patients able to have bronchoscopic placement of Calypso as confirmed on a recent (within the past 8 weeks) CT scan.
  • Patients who are able to comply with the protocol follow-up schedule.

Exclusion Criteria:

  • Patients unable to comply with instructions for DIBH
  • Patients with implants in the chest region that contain metal or conductive materials (e.g., metal implants, rods, or plates) which Calypso Medical considers will interfere with the Calypso System's electromagnetic localization.
  • Patients with active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps since the effects of the Calypso System operation on these devices are unknown.
  • Patients with clinically significant active infections.
  • Patients with bronchiectasis in the region of the intended implantation sites.
  • Patients with a history of hypersensitivity to nickel.
  • Patients whose lung tumors are being monitored with MR imaging (MR imaging of the anchored transponders is safe but yields an image artifact around the anchored transponders).
  • Posterior lesions that would be >19cm distance from Calypso detector plate. Patients may be treated in the prone position in order to meet the required minimum distance.
  • Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical study.
  • Patients who are deemed unable to safely undergo or tolerate flexible bronchoscopy
  • Patients who are unable to tolerate anesthesia or sedation
  • Patients enrolled in any other clinical studies the investigator believes to be in conflict with this investigation.
  • Female patients who are pregnant or nursing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02111681

Contacts
Contact: Andreas Rimner, MD 212-639-6025
Contact: Michael Lovelock, PhD 212-639-6032

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andreas Rimner, MD    212-639-6025      
Contact: Michael Lovelock, PhD    212-639-6032      
Principal Investigator: Andreas Rimner, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Varian Medical Systems
Investigators
Principal Investigator: Andreas Rimner, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02111681     History of Changes
Other Study ID Numbers: 13-174
Study First Received: April 9, 2014
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Calypso-based Deep Inspiration Breath Hold (DIBH)
radiation treatments
13-174

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Aspiration
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 23, 2014